While information on the known risks is available in the Risk Management Plans (RMPs), missing information include the use in pregnancy, immunocompromised patients, patients with comorbidities, autoimmune or inflammatory diseases and long-term safety data.
TORONTO (PRWEB)
March 08, 2023
Since December 2019, when the SARS-CoV-2 novel coronavirus was first reported in Wuhan, China, the pandemic has infected more than 750 million people and claimed more than 6.8 million lives. Subsequent vaccine discovery and implementation has allowed us to move forward out of the pandemic — over 13 billion vaccine doses have been administered to date. However, the exceptionally fast pace of development of the vaccines, and the accelerated approval process meant the long-term effects of covid vaccines remained inconclusive.
While information on the known risks is available in the Risk Management Plans (RMPs), missing information include the use in pregnancy, immunocompromised patients, patients with comorbidities, autoimmune or inflammatory diseases and long-term safety data.
To facilitate collection of this additional safety data, the vaccines were approved globally with the provision that the Market Authorization Holders (MAHs) carry out further pharmacovigilance activities as documented in RMPs.
As a response to the growing need for analysing ever growing data volumes and the need for increased granularity, ICON has developed advanced intelligent tools used to collect, analyze and visualize large amounts of safety data originating from different sources. The tools are designed to create dashboards, charts and reports that display relevant information in an easy-to-understand format: Post-marketed signal detection utilizing MAH-specific data and data from public databases, literature; Technical solution for data assessment via a data visualisation tool; Tracking of signals and Risk Minimization Measures; Aggregate data review and summary in aggregate safety reports — facilitate drafting and submission; And post-authorisation safety studies conducted by the vaccine manufacturers, as required by regulators, as well as other longitudinal observational studies that complement knowledge from clinical trials.
Join the featured speakers as they explore the challenges in assessing the long-term effects of Covid and Covid vaccines and how ICON’s advanced data analysis techniques can manage large amounts of safety data.
Join experts from ICON, Robina Azam, Director Patient Safety, Pharmacovigilance & Patient Safety; and Rakan Bitar, Senior Director Pharmacovigilance and Patient Safety, for the live webinar on Wednesday, March 29, 2023, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Challenges in Assessing Long-Term Effects of Covid and Covid Vaccines.
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Vera Kovacevic
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